In 2013, FDA introduced a new set of regulations that would establish a unique device identification system for medical devices. They also announced the dates for implementation, which would be done according to device classification. This set of regulations, called the Global Unique Device Identification Database (GUDID) would ensure compliance with the Agency’s required labeling and data submissions (full guidance here).
Earlier this month, FDA took the system offline after discovering a security vulnerability. Because of this, the Agency has announced that the compliance date for “non-class III implantable, life-supporting and life-sustaining medical devices” will be extended from September 24, 2015 to October 24, 2015 (see full guidance here).
We can help ensure your device and company is compliant with FDA regulations! Our unique approach, which combines a deep scientific knowledge with extensive regulatory expertise, has helped a number of our clients ensure compliance and get through FDA successfully. For more information on how we can help you, please contact us.